We delight in producing on your behalf

Our contract manufacturing department is an independent part of the HENNIG ARZNEIMITTEL company. It focuses on the production of solid, divided forms of drugs such as tablets, film-coated tablets, micro-tablets, layered tablets, pellets, capsules, powder and granulates, including those with substances subject to controlled release.

The contract manufacturing department at HENNIG ARZNEIMITTEL has special know-how in the production of medicinal products with time-controlled release of active substances. All most widely recognised methods for the modulation of active substance release are used, for example erosion and diffusion systems based on embedding and multi-compartment matrices, sequential decomposition control, wax embedding and solid solutions. Medicinal products with particularly fast and delayed active substance release are routinely manufactured in this way.

The planning and performance of manufacturing validations round off our range of contract manufacturing services.

Today's standard analytical procedures are carried out by means of a LIMS quality control system. The quality control of medicinal products, method developments and method improvements, including the necessary validations, are performed on a rou-tine basis. Qualified climatic chambers are available for stability checks in accordance with the relevant guidelines, including those for products with controlled substances.

For new product development and product improvements a high-performance pharmaceutical development unit is integrated into the contract manufacturing organisation.

A competent regulatory department is responsible for compiling CMC documents for marketing authorisation procedures and oversees regulatory processes. IMPD and CTD documents are drawn up upon request.

HENNIG ARZNEIMITTEL is therefore able to offer its customers a full service with end-to-end support: development, production, packaging, quality control, stability checks, logistics support, advice on product launches, the drafting of marketing authorisation documents, support with regulatory measures and problems, as well as with questions concerning quality assurance.

Any questions?

If you have any questions concerning contract manufacturing, please do not hesitate to contact us!